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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field service report # (b)(4). Symptom: pump has intermittent high baseline alarms on patient. Pump was switched out quickly with no complications findings/action taken: replaced pump assy. Returning on (b)(4). Also perform peventative maintence (pm). Fcn level: (b)(4). Software level: 2. 24 op
=
on patient confirmed.
 
Manufacturer Narrative
(b)(4) the reported alarm could not be replicated at teleflex (b)(4); however, excessive noise was noted and the pump alarmed system error 3 approximately 2 hours after initiating pumping. There was no reported patient injury or complications. Teleflex will continue to monitor for any developing trend.
 
Event Description
It was reported via a field service report # l611391. Symptom: pump has intermittent high baseline alarms on patient. Pump was switched out quickly with no complications findings/action taken: replaced pump assy. Returning on ar# (b)(4). Also perform preventative maintenance (pm). Fcn level: 1416, software level: 2. 24, op
=
on patient, confirmed.
 
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Brand NameAUTOCAT2 WAVE
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
carmen sherman
3015 carrington mill blvd
morrisville, PA 27560
6104783117
MDR Report Key6080171
MDR Text Key59225992
Report Number1219856-2016-00249
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberIAP-0500
Device Lot Number0001117068
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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